To Evaluate the Efficacy of TQB3823 Combined With Abiraterone and Prednisone in Metastatic Castration-resistant Prostate Cancer Patientsprednisone Acetate Tablets in Patients With Metastatic Castration-resistant Prostate Cancer

NCT ID: NCT05405439

Last Updated: 2023-11-03

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 39 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-25
• Study Completion Date: 2023-07-19

Brief Summary

This is a phase Ib/II clinical study to explore the safety and efficacy of TQB3823 tablets combined with abiraterone acetate tablets and prednisone acetate tablets in patients with metastatic castration-resistant prostate cancer.

Detailed Description

This is a two-phase, open-label Phase Ib clinical trial. The first phase plans to enroll 6-12 patients as two cohorts to explore the safety and of TQB3823 tablets combined with abiraterone and prednisone and the recommended dose of phase II of TQB3823. Subjects involved in cohort one accepts TQB3823 treatment during cycle one and then TQB3823 combined with abiraterone and prednisone from cycle two till the disease progression. The second phase plans to enroll a total of 40-60 subjects, aiming to evaluate the safety and efficacy of TQB3823 tablets combined with abiraterone and prednisone.

Conditions

Metastatic Castration-resistant Prostate Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

TQB3823 tablets + abiraterone acetate tablets + prednisone acetate tablets

TQB3823 tablets + abiraterone acetate tablets + prednisone acetate tablets，28 days as a treatment cycle.

Group Type: EXPERIMENTAL

TQB3823 tablets

Intervention Type: DRUG

TQB3823 tablet is an inhibitor of poly ADP-ribose polymerase (PARP).

Abiraterone acetate tablets

Intervention Type: DRUG

Abiraterone acetate tablet is an inhibitor of cytochrome P450 17（CYP17）

prednisone acetate tablets

Intervention Type: DRUG

Prednisone acetate tablet is a kind of glucocorticoids

Interventions

TQB3823 tablets

TQB3823 tablet is an inhibitor of poly ADP-ribose polymerase (PARP).

Intervention Type: DRUG

Abiraterone acetate tablets

Abiraterone acetate tablet is an inhibitor of cytochrome P450 17（CYP17）

Intervention Type: DRUG

prednisone acetate tablets

Prednisone acetate tablet is a kind of glucocorticoids

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male patients aged 18 to 85.
• Subjects with pathologically proven with prostate adenocarcinoma.
• Metastatic disease confirmed by imaging (eg, bone scan and CT/MRI).
• The patient's serum testosterone level at the screening visit was ≤ 1.73 nmol/L (50 ng/dL). Patients who did not undergo bilateral orchiectomy required continued ADT [gonadotropin-releasing hormone analog (LHRHa, agonist/antagonist)] treatment throughout the study period.
• Disease progression during consecutive androgen deprivation therapy (ADT), defined at study entry, as meeting one or more of the following criteria:

1. At least two consecutive PSA elevations separated by at least 1 week, the last result must be at least 1.0 ng/mL.

2. Soft tissue lesion progression as assessed by RECIST 1.1 with or without PSA progression.

3. Bone disease progression assessed by PCWG3, i.e., ≥2 new lesions detected on bone scan, ≥2 new bone lesions other than those previously assessed on reassessment at least 8 weeks later, with ≥2 previously assessed bone lesions still exist, regardless of PSA progression.

• Patients must discontinue all prior cancer therapy (except ADT and bone loss prophylaxis) and have recovered to ≤ Grade 1 or baseline (according to the Common Terminology Criteria for Adverse Events) prior to first dose of all acute toxic effects of prior therapy or surgery Version 5.0 [CTCAE v 5.0]), with the exception of alopecia and peripheral neuropathy, and the washout period since the last prior systemic or radiation therapy was as follows:

1. At least 4 weeks must have elapsed since enrollment with 5-alpha reductase inhibitors (eg, dutasteride, finasteride), estrogen, and cyproterone.

2. At least 4 weeks must have elapsed from major surgery or radiation therapy to enrollment。

• Laboratory indicators meet the requirements.

Exclusion Criteria

• For subjects with brain metastases with symptoms or symptom control for less than 1 month, screening for CNS metastases at baseline is not required unless there are signs and/or symptoms of CNS involvement.
• Subjects who have developed or is currently suffering from other malignancies within 3 years, except for cured skin basal cell carcinoma and cervical carcinoma in situ.
• Subjects who have accepted botanicals (such as saw palmetto) that may lower PSA levels within 4 weeks before the first dose.
• Subjects who have accepted oral targeted drugs within 5 drug half-lives from the first dose (calculated from the end of the last treatment).
• Subjects who have not recovered to ≤ Common Terminology Criteria for Adverse Events (CTCAE) Grade 1 due to the adverse event of prior therapy.
• Subjects who have previously accepted CYP17 enzyme inhibitors (including drugs such as abiraterone, TAK-700, TOK-001, and ketoconazole, ect.,) or second generation androgen receptor inhibitors (including enzalutamide, apalutamide, darolutamide , etc.) (mHSPC, nmCRPC stage).

1. The study accept patients who received McRpc-based chemotherapy with CYP17 inhibitors other than abiraterone or second-generation androgen receptor inhibitors or paclitaxel for less than 3 months without disease progression, However, 4 weeks or 5 half-life washing out period is required (whichever is longer).

2. Patients who received abiraterone in the mCRPC phase for less than 3 months and did not progress (no need to stop elution) are allowed in the study, but cannot be enrolled in the phase I cohort of a single drug population in this study.

• Subjects who receive medications known to be potent inhibitors of cytochrome P450 3A4 (CYP3A4) or potent or moderate inducers and unable to discontinue these medications or switch to another for at least 5 half-lives prior to initiation of study medication different medicines.
• Subjects who suffer from contraindications to prednisone (corticosteroid) use, such as active systemic infection (e.g. bacterial infection requiring intravenous antibiotics at initiation of study treatment, fungal infection, or detectable viral infection requiring systemic therapy ) or viral load (e.g. known HIV positive or known active hepatitis B or C (e.g. hepatitis B surface antigen positive). Screening for contraindications other than HIV/HBV and HCV is not required to determine eligibility.
• Subjects with history of idiopathic pulmonary fibrosis, organizing pneumonia (eg, bronchiolitis obliterans), drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on a chest CT scan during screening.
• Subjects with any chronic condition requiring corticosteroid treatment at doses greater than "Prednisone 5mg, BID";

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: No

Sponsors

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

The First Hospital of Peking University

Beijing, Beijing Municipality, China

The Southwest Hospitai of Amu

Chongqing, Chongqing Municipality, China

Chongqing Cancer Hospital

Chongqing, Chongqing Municipality, China

The Second Hospital of Harbin Medical University

Lanzhou, Gansu, China

Sun Yat-Sun University Cancer Prevertion and Treatment Center

Guangzhou, Guangdong, China

Qingyuan People's Hospital

Qingyuan, Guangdong, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, Guangxi, China

Affiliated Cancer Hospital of Harbin Medical University

Harbin, Heilongjiang, China

Hunan Cancer Hospital

Changsha, Hunan, China

Jiangsu Province Hospital

Nanjing, Jiangsu, China

Shengjing Hospital Affiliated to China Medical University

Shenyang, Liaoning, China

Shandong Cancer Hospital

Jinan, Shandong, China

Huadong Hospital Affiliated to Fudan University

Shanghai, Shanghai Municipality, China

The First Affiliated Hospital of The Chinese People's Liberation Army Air Force Military Medical University

Xi’an, Shanxi, China

West China Hospital，Sichuan University

Chengdu, Sichuan, China

Sichuan Provincial People's Hospital

Chengdu, Sichuan, China

The Affiliated Hospital of Southwest Medical University

Luzhou, Sichuan, China

Mianyang Central Hospital

Mianyang, Sichuan, China

Zigong Fourth People's Hospital

Zigong, Sichuan, China

Cancer Hospital of Tianjin Medical University

Tianjin, Tianjin Municipality, China

The First Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

Second Affiliated Hospital of Kunming Medical University

Kunming, Yunnan, China

The First Affiliated Hospital of Wenzhou Medical Univerity

Wenzhou, Zhejiang, China

Countries

China

Other Identifiers

TQB3823-Ib/II-01

Identifier Type: -

Identifier Source: org_study_id